Vascular device for valve leaflet apposition

• US 7,041,128 B2
• Filed: 01/28/2004
• Issued: 05/09/2006
• Est. Priority Date: 06/26/2000
• Status: Expired due to Term

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Briganti, Richard T.
• Primary Examiner(s): Thanh, Quang D.
• Application Number:
  US10/766,061
• Publication Number:
  US 20040186561A1
• Time in Patent Office: 832 Days
• Field of Search: 623/1.11, 623/1.14, 623/1.18, 623/1.19, 623/1.23, 623/1.24, 623/1.36, 623/902, 623/903, 606/151, 606/152, 606/153, 606/154, 606/155, 606/195, 600/37
• US Class Current: 623/1.36
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A vascular system comprising a balloon catheter having an elongated shaft and an expandable balloon. A vascular device is mounted over the expandable balloon and composed of shape memory material and has a collapsed position and a memorized position. The vascular device is expandable to an expanded position, to engage the vessel walls and returnable substantially to the memorized position to bring the walls radially inwardly.

Claims

1. A vascular system for treating venous valve insufficiency comprising:

a balloon catheter having an elongated shaft and an expandable balloon;

a vascular device mounted over the expandable balloon and composed of shape memory material and having a collapsed position for delivery and a memorized position for placement within a vessel lumen, the vascular device having vessel engaging members, the vascular device expandable to an expanded position by inflation of the expandable balloon to engage the vessel walls such that the vessel engaging members grasp the vessel walls and the vascular device is subsequently returnable substantially to the memorized position such that the vessel engaging members bring the walls radially inwardly to thereby reduce a diameter of the vessel lumen to bring valve leaflets into apposition.

2. The vascular system of claim 1, wherein the vascular device is expandable first to the memorized position in response to exposure to body temperature and subsequently expanded to the expanded position by inflation of the balloon.

3. The vascular system of claim 1, wherein the vascular device is expandable to the expanded position as the device is substantially simultaneously exposed to body temperature and the balloon is inflated.

4. The vascular system of claim 3, wherein the vascular device is connected to the balloon.

5. The vascular system of claim 4, further comprising a pair of looped sutures connecting the vascular device to the balloon, the sutures separable from the vascular device upon expansion of the balloon to a predetermined size.

6. The vascular system of claim 1, further comprising a sheath, the balloon catheter positioned within the sheath, and wherein release of the vascular device from the sheath enables it to expand to the memorized position.

7. The vascular system of claim 6, wherein the vascular device is maintained in the collapsed position inside the sheath at a temperature below its transition temperature.

8. The vascular system of claim 7, wherein the catheter includes an inflation lumen communicating with the balloon, wherein inflation of the balloon expands the device to a diameter larger than the diameter of the vascular device and subsequent deflation of the balloon results in the device contracting towards the memorized position.

9. The vascular system of claim 1, wherein the vascular device is formed from a laser cut tubular member.

10. The vascular system of claim 9, wherein the balloon catheter includes an outer sheath slidable with respect to the catheter shaft to expose the vascular device.

11. The vascular system of claim 10, wherein the vascular device is maintained in the collapsed position inside the sheath at a temperature below its transition temperature.

12. The vascular system of claim 1, wherein the catheter includes an inflation lumen communicating with the balloon, wherein inflation of the balloon expands the device to a diameter larger than the diameter of the vascular device and subsequent deflation of the balloon results in the device contracting towards the memorized position.